hct with ptcy in higher-risk mds

Conditions: Patients With MDS, Acute Myeloid Leukemia (AML) Evolving From MDS, and Chronic Myelomonocytic Leukemia (CMML)

Summary: this study is conducted to evaluate the efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation (hct) in patients with higher-risk myelodysplastic syndrome (mds). the efficacy of the treatment will be measured in terms of the gvhd-free, relapse-free survival. the secondary end points of the study include engraftment, relapse incidence, non-relapse mortality, graft-versus-host disease, donor chimerism, immune reconstitution, infections, and survivals (overall and event-free).

this study is conducted to evaluate the efficacy of post-transplantation cyclophosphamide with myeloablative or reduced-intensity conditioning regimen for allogeneic hematopoietic cell transplantation (hct) in patients with higher-risk myelodysplastic syndrome (mds). the efficacy of the treatment will be measured in terms of the gvhd-free, relapse-free survival. the secondary end points of the study include engraftment, relapse incidence, non-relapse mortality, graft-versus-host disease, donor chimerism, immune reconstitution, infections, and survivals (overall and event-free).

Eligibility criteria:
inclusion criteria: * mds defined by who classification, cmml, or aml evolving from mds a. international prognostic scoring system (ipss) \> 1.0 or bone marrow blast ≥ 5% at any time points before hct or b. aml progressed from mds or c. cmml with bone marrow blast ≥ 5% at any time points before hct * patients receiving first hct * patients with appropriate hematopoietic cell donors a. hla-matched sibling donor b. unrelated donor c. hla-mismatched familial donor * 15 years old or older , under 75 years * adequate performance status (karnofsky score of 70 or more) * adequate hepatic function (ast or alt \< 3 x upper normal limits and bilirubin \< 1.5 x upper normal limit). * adequate renal function (creatinine \< 2.0 mg/dl or creatinine clearance ≥ 50 ml/min) * adequate cardiac function (left ventricular ejection fraction ≥ 50% on heart scan or echocardiogram) * adequate pulmonary function: dlco, fev1, and fvc ≥ 45% predicted by pulmonary function tests * signed and dated informed consent must be obtained from both recipient and donor. exclusion criteria: * presence of significant active infection * presence of uncontrolled bleeding * any coexisting major illness or organ failure * patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible * nursing women, pregnant women, women of childbearing potential who do not want adequate contraception * patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia) * presence of contraindications to cyclophosphamide (patients receiving pentostatin, symptomatic cystitis, urinary tract obstruction, with a history of hypersensitivity reactions to the component of the drug)